Use of Graft Jacket for Rotator Cuff Repair

This study has been completed.
Sponsor:
Collaborators:
Sports Medicine & Arthroscopic Surgery Bone & Joint Clinic of Houston
Southern California Orthopedic Institute Medical Group
Kelsey-Seybold Clinic of Orthopaedics
Plano Orthopedic & Sports Medicine Center
St Joseph's Hospital Hand & Upper Limb Center
Fowler Kennedy Sport Medicine Clinic
St. Boniface General Hospital Research Centre
Information provided by (Responsible Party):
Robert Litchfield, MD, FRCSC, Fowler Kennedy Sport Medicine Clinic
ClinicalTrials.gov Identifier:
NCT00456781
First received: February 21, 2007
Last updated: July 2, 2014
Last verified: July 2014
  Purpose

This study is to evaluate the safety and effectiveness of GraftJacket, a human tissue product used in fixing large and massive reparable rotator cuff tears.GraftJacket allograft (Wright Medical Technology, Inc., Arlington, TN) is a biologic tissue that is derived from human dermis. The primary purpose of this study is to determine whether rotator cuff repair augmentation using GraftJacket allograft provides a viable alternative, based on observed clinical outcomes, versus outcomes traditionally achieved with suture and anchor repairs. The study will secondarily investigate the difference in outcomes in patients treated arthroscopically versus open. This study will report patient progress and results at early (6 month) and late (2 year) time points in patients treated for large and massive reparable rotator cuff tears (>3cm). A reparable tear is defined as a tear of the rotator cuff where it is possible to bring the retracted tendon edge back to the greater tuberosity of the humerus without excessive tension. Restoration of rotator cuff integrity, clinical outcomes and re-tear rate will be included in the study evaluations.


Condition Intervention
Rotator Cuff Tear
Device: Augmentation
Procedure: Rotator Cuff Repair without augmentation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: GraftJacket® Rotator Cuff Tendon Reinforcement Scaffold: A Randomized Prospective Clinical Evaluation

Resource links provided by NLM:


Further study details as provided by Wright Medical Technology:

Primary Outcome Measures:
  • less or no recurrence of shoulder rotator cuff tear with the use of the tissue scaffold than with the standard use of surgical anchors and screws as measured by MRI results [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    each subject will be eligible for the study based on the Pre-operative results of the MRI as it relates to the size of the tissue tear. The subjects will be assigned to either the tissue scaffold material or the standard surgical suture or anchors. Then, the procedure to repair is determined by the investigator as an arthoscopic or open procedure. Pos-operative evalutions via MRI will be obtained throughout the study to evaluate the effectiveness of the surgical procedure and for the measurement of retear or not.


Secondary Outcome Measures:
  • Scale (pain, ADL, Shoulder stability) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    A baseline evaluation for pain scale, activity of daily living measurement and range of motion to determine injured and repaired shoulder stability

  • UCLA Shoulder Score (pain, function, manual muscle testing) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    Pain, function, manual muscle testing measured per UCLA Shoulder Score at baseline and at intervals at up to two years.

  • Constant-Murley Shoulder Score (pain, function, ROM, Strength) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    Pain, function, ROM, and Strength measured per Constant-Murley Shoulder Score at baseline and at intervals at up to two years.

  • Surgeon Reported Satisfaction [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Enrollment: 79
Study Start Date: April 2007
Study Completion Date: March 2011
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Augmentation
Rotator Cuff Repair augmented with the Graft Jacket Device
Device: Augmentation
Rotator Cuff Repair plus Graft Jacket
Other Name: Wright Medical Technology Graft Jacket
Active Comparator: No Augmentation
Rotator Cuff RFepair
Device: Augmentation
Rotator Cuff Repair plus Graft Jacket
Other Name: Wright Medical Technology Graft Jacket
Procedure: Rotator Cuff Repair without augmentation
Rotator Cuff Repair without augmentation

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Patients between the ages of 18 - 75 years inclusive,
  2. Reads, understand and able to complete the patient reported outcomes in English,
  3. Patients with large and massive rotator cuff tears of more than 3cm, which can be repaired either arthroscopically or by open surgery.,
  4. Patients with either primary or revision rotator cuff tears measuring < 5cm with at least 2 tendon involvement as indicated by MRI,
  5. Patients who have a reasonable movement of the non-operative arm, defined as a shoulder elevation of equal or more than 90°, and are able to perform (postoperative) exercises,
  6. Patients for whom there is a reasonable expectation that he or she will be available for each protocol required post-operative follow-up examination,
  7. Patients must complete the informed consent process (including any regulatory requirements such as HIPAA authorization) agreeing to participate and signing the informed consent form prior to the site conducting any study related procedures.

Exclusion Criteria:

  1. Patients with irreparable large or massive rotator cuff tears <3cm will be excluded if found intra-operatively
  2. Patients with rotator cuff tears where the subscapularis tendon is disrupted,
  3. Patients with inflammatory or auto-immune based joint diseases (e.g., rheumatoid arthritis, systemic lupus erythematosus),
  4. Patients with evidence of active infection, cancer, or highly communicable diseases that would preclude the patient from completing required patient assessments and clinic visits as described in the protocol,
  5. Patients who smoke,
  6. Patients with a documented history of drug abuse within six months of treatment,
  7. Any other condition, that in the opinion of the investigator, that would preclude the patient from enrollment.
  8. Females of child-bearing potential who are pregnant or breastfeeding, or plan to become pregnant during the course of the study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00456781

Locations
United States, California
Southern California Orthopedic Institute
Simi Valley, California, United States, 93063
United States, Texas
Bone and Joint Clinic of Houston
Houston, Texas, United States, 77005
Kelsey-Seybold Orthopedic
Houston, Texas, United States, 77025
Plano Orthopedic & Sports Medicine
Plano, Texas, United States, 75093
Canada, Manitoba
Pan Am Clinic
Winnipeg, Manitoba, Canada, RM3-3E4
Canada, Ontario
Fowler Kennedy Sport Medicine Clinic
London, Ontario, Canada, N6A 3K7
The Hand and Upper Limb Centre
London, Ontario, Canada, NSA-4L6
Sponsors and Collaborators
Wright Medical Technology
Sports Medicine & Arthroscopic Surgery Bone & Joint Clinic of Houston
Southern California Orthopedic Institute Medical Group
Kelsey-Seybold Clinic of Orthopaedics
Plano Orthopedic & Sports Medicine Center
St Joseph's Hospital Hand & Upper Limb Center
Fowler Kennedy Sport Medicine Clinic
St. Boniface General Hospital Research Centre
Investigators
Principal Investigator: Robert Litchfield, MD, FRCSC Fowler Kennedy Sport Medicine Clinic
  More Information

No publications provided

Responsible Party: Robert Litchfield, MD, FRCSC, Study Principal Investigator, Fowler Kennedy Sport Medicine Clinic
ClinicalTrials.gov Identifier: NCT00456781     History of Changes
Other Study ID Numbers: Wright1
Study First Received: February 21, 2007
Last Updated: July 2, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Wright Medical Technology:
rotator cuff
randomized clinical trial

ClinicalTrials.gov processed this record on August 19, 2014